Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

NCT00499694 | Completed Results DMC

• 3 other identifiers: CDR0000518085P30CA022453WSU-2006-118
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.

  Every 70 days

Secondary Outcomes (3)

• Toxicity, Presented as the Number of Participants With Adverse Events

  Day 1 of every cycle (35 days) and Day 15 of every cycle

• Percentage of Participants With Prostate-specific Antigen (PSA) Response

  Day 1 of every cycle (35 days) and Day 15 of every cycle

• Overall Survival

  Followed every 3 months after treatment is discontinued

Study Arms (1)

Bevacizumab and Satraplatin

EXPERIMENTAL

Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days

Biological: bevacizumab; Drug: satraplatin

Interventions

bevacizumab BIOLOGICAL

10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Also known as: Avastin ®

Bevacizumab and Satraplatin

satraplatin DRUG

80 mg/m(2), Orally, Days 1-5, every 35 days

Bevacizumab and Satraplatin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: * Metastatic disease * Objective progression or rising prostate-specific antigen (PSA) despite androgen-deprivation therapy and antiandrogen withdrawal * Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week * Minimum PSA of 5 ng/mL or new areas of bony metastases on bone scan required if no measurable disease * No minimum PSA for measurable disease * Must have received ≤ 1 prior docetaxel-based chemotherapy for metastatic disease * No known CNS disease or brain metastases * Testosterone \< 0.5 ng/mL (castrate level) * Concurrent luteinizing-hormone releasing-hormone agonist allowed to maintain castrate level PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Bilirubin normal * Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min * Urine protein:creatinine ratio ≤ 1.0 OR proteinuria ≤ 2+ by urine dipstick OR ≤ 1 g protein/24-hour urine collection * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * No significant traumatic injury within the past 28 days * Adequately controlled hypertension (defined as systolic blood pressure \[BP\] ≤ 150 mm Hg and/or diastolic BP ≤ 100 mm Hg on antihypertensive medications) * No history of hypertensive crisis or hypertensive encephalopathy * No New York Heart Association class II-IV congestive heart failure * No myocardial infarction or unstable angina within the past 6 months * No stroke or transient ischemic attack within the past 6 months * No significant vascular disease (e.g., aortic aneurysm, aortic dissection) * No symptomatic peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No prior malignancy except adequately treated skin cancer or any other cancer in complete remission for ≥ 2 years * Able to swallow and retain capsules * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious nonhealing wound, ulcer, or bone fracture * No known hypersensitivity to any component of bevacizumab * No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab * No uncontrolled intercurrent illness, including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness or social situation that would preclude compliance with study requirements * No HIV positivity * No immune deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior flutamide * More than 6 weeks since prior bicalutamide or nilutamide * At least 4 weeks since prior radiotherapy * At least 2 weeks since prior minor surgery * More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device) * More than 28 days since prior major surgery or open biopsy (8 weeks if high-risk procedure such as liver resection, thoracotomy, or neurosurgery) * Concurrent low-dose aspirin (≤ 325 mg/day) allowed * Concurrent anticoagulants allowed if patient has been on therapy ≥ 4 weeks and has no acute thromboembolic activity * No concurrent major surgery * No concurrent aprepitant * No concurrent immunosuppressive therapy * No concurrent combination anti-retroviral therapy for HIV-positive patients * No other concurrent antitumor therapy (including radiotherapy) * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bevacizumab; satraplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Small sample size, correlative ERCC testing conducted in only a subset of patients (14 of 30 pts) and the findings of this study are hypothesis generating however validation in larger sample size would be needed.

Results Point of Contact

• Title: Ulka Vaishampayan, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

vaishamu@karmanos.org

(313) 576-8718

Study Officials

• Ulka N. Vaishampayan, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 12, 2018
• Results First Posted: August 25, 2014

Record last verified: 2018-05

Locations

US (2)